The Russian Direct Investment Fund (RDIF), R-Pharm group and AstraZeneca have reported interim safety data of Phase II clinical trials analysing the combination of AstraZeneca’s Covid-19 vaccine and the Sputnik Light vaccine.
Based on recombinant human adenovirus serotype number 26, single-dose Sputnik Light is the first component of the Sputnik V vaccine.
AstraZeneca’s vaccine was invented jointly by the University of Oxford in the UK and Vaccitech. It leverages a replication-deficient viral vector based on adenovirus and has the SARS-CoV-2 spike protein genetic material.
The trials enrolled 100 subjects each in Russia and Azerbaijan, as well as analysed the safety and immunogenicity of Sputnik Light combined with AstraZeneca’s vaccine.
Interim data showed that the vaccine combination offered an acceptable safety profile, which is in line with data from the previous trials of the AstraZeneca vaccine, Sputnik V and Sputnik Light.
The trial subjects are currently being observed for 57 days following the first dose.
According to the data, the combination of the vaccines demonstrated a good safety profile without any serious adverse events linked to the inoculation reported.
Carried out by the RDIF, the Gamaleya Center, AstraZeneca and R-Pharm, the study is the first in the world to analyse the usage of components from multiple adenovirus vaccines in combination to prevent Covid-19.
The parties signed a memorandum in December 2020 to conduct a joint Phase II trial to assess the safety and immunogenicity of vaccines combination of AstraZeneca’s shot and Sputnik V.
This trial is being conducted in Azerbaijan, Russia and the UAE, with subjects set to receive intramuscular doses of the AstraZeneca’s vaccine and the Ad26-S component of the Sputnik V in varying sequences at a gap of 28 days.
RDIF CEO Kirill Dmitriev said: “Preliminary data from the trial to test Sputnik Light and AstraZeneca vaccines combination support the ‘mix and match’ approach to revaccination.
“With new dangerous variants of concern emerging, this approach could provide safe, effective and long-term protection.”
In September 2021, the RDIF reported that a combination of AstraZeneca’s Covid-19 vaccine with Sputnik Light demonstrated strong growth in neutralising antibodies in a trial in Azerbaijan.